MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-24 for ENROUTE NEUROPROTECTION SYSTEM SR-200-NPS manufactured by Silk Road Medical.
[189080809]
The product associated with this complaint was not returned to the manufacturer for analysis. A review of manufacturing records for this device was completed and no issues were identified that could have lead to the adverse event reported. Complaints will continue to be reviewed and monitored for trends.
Patient Sequence No: 1, Text Type: N, H10
[189080810]
Patient underwent transcarotid arterial revascularization where the physician had difficulty advancing the arterial sheath into position. Physician had further difficulties advancing the guidewire to the lesion after reverse flow was established. Subsequent steep angle angiogram revealed dissection plane. Attempts made to retract the sheath and maneuver around the plane were unsuccessful. The sheath was removed, and access was regained through a new access point. The procedure was performed successfully and a second stent was placed proximally to the sheath tip. Patient remained stable throughout procedure and awoke neurologically intact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014526664-2020-00048 |
| MDR Report Key | 9872031 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-06-26 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SHARON RIDEOUT |
| Manufacturer Street | 1213 INNSBRUCK DRIVE |
| Manufacturer City | SUNNYVALE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 7209002 |
| Manufacturer G1 | SILK ROAD MEDICAL |
| Manufacturer Street | 1213 INNSBRUCK DRIVE |
| Manufacturer City | SUNNYVALE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENROUTE NEUROPROTECTION SYSTEM |
| Generic Name | NPS |
| Product Code | NTE |
| Date Received | 2020-03-24 |
| Model Number | SR-200-NPS |
| Catalog Number | SR-200-NPS |
| Lot Number | 300844 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SILK ROAD MEDICAL |
| Manufacturer Address | 1213 INNSBRUCK DRIVE SUNNYVALE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |